Liraglutide for HIV-associated Neurocognitive Disorder

• Status: Suspended
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will test the effect of liraglutide on cognitive function in HIV-infected overweight or obese subjects with type 2 diabetes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Temple University
• Collaborator: The Comprehensive NeuroAIDS Center (CNAC) at Temple University
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

• HIV controlled on therapy for at least 12 weeks

• Viral load < 200 copies

• BMI >27 to 45

• Diagnosis of DM type 2 with A1-C >7 to 15

• Participants must be willing to comply with all study related procedures

Exclusion Criteria:

• Personal or family history of pancreatitis

• Medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2)

• Gastroparesis

• Allergy to liraglutide or any of the active ingredients in liraglutide or other GLP-1 analogue

• Weight loss drugs other than metformin

• Type 1 diabetes mellitus or diabetic ketoacidosis

• Known major cognitive deficit dementia, history of head trauma with loss of consciousness >30 min, history of stroke, current central nervous system (CNS) disorder such as seizures or opportunistic CNS infection

• Renal insufficiency defined as creatinine clearance < 60 mL/min

• Active opportunistic infections

• Pregnancy or breastfeeding

• Unstable cardiovascular disease with hospitalization within 1 year for acute coronary syndrome

• Decompensated heart failure

• Substance abuse

• Active alcohol or opioid substitution therapy

• Serious or unstable medical or psychological conditions that would compromise the subject's safety for successful participation